MEMBRANE FOR USE WITH IMPLANTABLE DEVICES

• US 20140335343A1
• Filed: 07/25/2014
• Published: 11/13/2014
• Est. Priority Date: 07/27/2001
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brauker, James H., Shults, Mark C., Tapsak, Mark A.
• Granted Patent: US 9,532,741 B2
• Time in Patent Office: Days
• US Class Current: 428/221
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: Y10T 428/249921 Web or sheet containing structurally defined element or component

Abstract

The present invention provides a biointerface membrane for use with an implantable device that interferes with the formation of a barrier cell layer including; a first domain distal to the implantable device wherein the first domain supports tissue attachment and interferes with barrier cell layer formation and a second domain proximal to the implantable device wherein the second domain is resistant to cellular attachment and is impermeable to cells. In addition, the present invention provides sensors including the biointerface membrane, implantable devices including these sensors or biointerface membranes, and methods of monitoring glucose levels in a host utilizing the analyte detection implantable device of the invention. Other implantable devices which include the biointerface membrane of the present invention, such as devices for cell transplantation, drug delivery devices, and electrical signal delivery or measuring devices are also provided.

Claims

1. A biointerface membrane for use with an implantable device comprising;

a) a first domain distal to said implantable device wherein said first domain supports tissue ingrowth and interferes with barrier cell layer formation; and

b) a second domain proximal to said implantable device wherein said second domain is resistant to cellular attachment and is impermeable to cells and cell processes.

2. A biointerface membrane according to claim 1 wherein said first domain is comprised of an open-cell configuration having cavities and a solid portion.

3. A biointerface membrane according to claim 2 wherein said open-cell configuration comprises a depth of greater than one cavity in three dimensions substantially throughout the entirety of the domain.

4. A biointerface membrane according to claim 2 wherein a substantial number of said cavities are not less than 20 microns in the shortest dimension and not more than 1000 microns in the longest dimension.

5. A biointerface membrane according to claim 2 wherein a substantial number of said cavities are not less than 25 microns in the shortest dimension and not more than 500 microns in the longest dimension.

6. A biointerface membrane according to claim 2 wherein said cavities and cavity interconnections are formed in layers having different cavity dimensions.

7. A biointerface membrane according to claim 2 wherein said solid portion has not less than 5 microns in a substantial number of the shortest dimensions and not more than 2000 microns in a substantial number of the longest dimensions.

8. A biointerface membrane according to claim 2 wherein said solid portion has not less than 10 microns in a substantial number of the shortest dimensions and not more than 1000 microns in a substantial number of the longest dimensions.

9. A biointerface membrane according to claim 2 wherein said solid portion has not less than 10 microns in a substantial number of the shortest dimensions and not more than 400 microns in a substantial number of the longest dimensions.

10. A biointerface membrane according to claim 2 wherein said solid portion comprises silicone.